Standards compliance in the medical sector: bringing power to life

Products for certain industries demand special attention, with the medical sector arguably top of the list. Medical equipment and devices are clearly high priority at present as the world continues to combat the COVID-19 pandemic. To ensure the best treatment for all who need it, medical systems must offer optimised, reliable performance, which in turn necessitates a high reliance on power. For this reason, when it comes to devices that could conceivably save lives, power supplies and battery chargers are not immune to the application of rigorous quality standards.

Experience is everything. A proven track record of working with medical OEMs to develop power supplies and chargers that meet specific needs is a huge consideration when seeking a suitable technology partner in this market. A key note here is to check that power-related products are certified by a recognised third party to EN/UL 60601-1 edition 3.1, a technical standard for the safety and essential performance of electro-medical devices. Such devices include blood pressure monitors, blood analysers, ventilators, defibrillators, infusion pumps and patient lifts, to list but a few.

The importance of EN/UL 60601-1 3rd edition is significant as it is regarded to specify the most severe requirements for factors such as insulation level, creepage distance, leakage current, isolation voltage, HV-tests and mechanical tests, which is why it is the preferred standard for Mascot solutions.

EN/UL 60601-1 has become a requirement for the commercialisation of electrical medical equipment in many countries. The 3rd edition extends patient focus to require an overall ‘means of protection’ (MOP) that combines one or more ‘means of operator protection’ (MOOP) and ‘means of patient protection’ (MOPP). So, although the basic provisions of the 2nd and 3rd editions to protect against failure are retained, the 3rd edition acknowledges that the potential hazards witnessed by each user can be very different.

All Mascot power solutions for the medical market are designed for reliability and performance, delivering robust characteristics and extra low leakage currents in line with other relevant standards, and not just EN/UL 60601-1 ed. 3.1. For instance, most Mascot products also comply with EMC EN 60601-1-2 edition 4.0, which applies to basic safety and performance of medical electrical equipment/systems in the presence of electromagnetic disturbances – as well as any electromagnetic disturbance emitted by the equipment itself. Then there is EN 60601-1-11, which concerns healthcare equipment and systems intended for use in home environments.

Of course, it is also possible to obtain third-party certification to other standards upon customer request, although it should be noted that there may be a cost issue associated with this task. In addition, suitable capacity for starting such a project may not be available.

Whatever the medical project, the objective ultimately remains the same: to ensure the health and safety of patients and medical professionals. In the current pandemic environment, where the reliability of medical equipment has never been more critical, there is a clear requirement to ensure that power supplies and chargers meet the necessary standards. No one should underestimate the cost of poor quality when lives could be at stake.

To discover more about Mascot power supplies and battery chargers in the medical sector, simply click here.